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WO2014076819A1 - Récipient d'emballage médical - Google Patents

Récipient d'emballage médical Download PDF

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Publication number
WO2014076819A1
WO2014076819A1 PCT/JP2012/079830 JP2012079830W WO2014076819A1 WO 2014076819 A1 WO2014076819 A1 WO 2014076819A1 JP 2012079830 W JP2012079830 W JP 2012079830W WO 2014076819 A1 WO2014076819 A1 WO 2014076819A1
Authority
WO
WIPO (PCT)
Prior art keywords
medical
packaging container
container
main body
packaging
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/JP2012/079830
Other languages
English (en)
Japanese (ja)
Inventor
俊介 長井
斉 藤岡
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Hogy Medical Co Ltd
Original Assignee
Hogy Medical Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Hogy Medical Co Ltd filed Critical Hogy Medical Co Ltd
Priority to PCT/JP2012/079830 priority Critical patent/WO2014076819A1/fr
Publication of WO2014076819A1 publication Critical patent/WO2014076819A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes or webs of flexible sheet material, e.g. in folded wrappers
    • B65D75/28—Articles or materials wholly enclosed in composite wrappers, i.e. wrappers formed by associating or interconnecting two or more sheets or blanks
    • B65D75/30—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
    • B65D75/32—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents
    • B65D75/325—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet being recessed, and the other being a flat not- rigid sheet, e.g. puncturable or peelable foil
    • B65D75/327—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet being recessed, and the other being a flat not- rigid sheet, e.g. puncturable or peelable foil and forming several compartments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B2050/005—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers with a lid or cover
    • A61B2050/0065—Peelable cover
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
    • A61B2050/3008—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments having multiple compartments

Definitions

  • the present invention relates to a medical packaging container for storing various medical devices used in, for example, a surgical operation, a surgical procedure, and the like.
  • the present invention packages various medical devices (also referred to as kits or combined medical devices) required for surgery and the like, and stores them in a sterile state, damaging the medical devices stored therein.
  • the medical packaging container that can be transported to a medical site without losing sterility and that can be efficiently used for the various medical devices that have been opened in the operating room and housed inside. It is about.
  • the medical equipment required for surgery, surgical procedures, etc. depends on the type of disease or illness to be operated on, the surgical field and the extent, and the corresponding procedure, as well as the procedures and procedures of hospitals and surgeons. Come different. For this reason, conventionally, a medical device required in a hospital is selected and prepared from medical devices provided in a hospital based on an instruction from a surgeon in accordance with an individual operation.
  • providing medical devices used for surgery as a kit can eliminate the task of providing medical devices required by medical personnel, but when using the kit, A new problem has arisen that medical devices need to be rearranged to be easy to handle. That is, in the package such as a bag containing the kit, the medical devices are not stored in the order of use, and after opening, it is necessary to rearrange them so that they are easy to use. At the surgical site, there is sometimes a conflict for every second, and it is not desirable if such a rearrangement is essential.
  • kits when a kit is made into a product, depending on the method of operation, there may be a case where the medical device has to be filled to the full capacity of the package, and when the package is opened, the load collapses, and medical treatment is started from the instrument table at the opening location. There is a possibility that the device falls and the medical device cannot be used for surgery.
  • the packaging body is a bag made of a plastic film that is not self-supporting, or a plastic tray or box that is somewhat rigid. Etc. were used.
  • the volume of waste can be reduced by reducing the volume of packaging materials as much as possible from the viewpoint of cost. (Volume) needs to be reduced.
  • the amount of medical waste (infectious waste) is calculated based on its volume, it is desirable to reduce the volume as much as possible. Therefore, for example, as seen in a general packing method, it is not realistic to use a buffer material such as an air packing.
  • a plastic tray or box it is difficult to easily crush it when it is discarded.
  • Patent Documents 1 to 6 As a general medical device package, for example, in Patent Documents 1 to 6, it is composed of a bag, a plastic tray, and a film material covering the upper portion thereof, which is formed of a low oxygen permeable plastic film or plastic sheet. What uses a container body in combination with an oxygen absorber is disclosed.
  • Patent Document 7 discloses a tray formed in a kit for storing and transferring a medical device after processing or use, in which at least one fold line is formed on the bottom and / or wall surface thereof. In addition, it is disclosed that the volume of the tray is reduced by being folded at the folding line at the time of disposal.
  • the medical device package as described in Patent Documents 1 to 6 can be used as a medical packaging container for packaging a kit including various medical devices required in the above-described surgical operation or the like.
  • a medical packaging container for packaging a kit including various medical devices required in the above-described surgical operation or the like can be used as described above (1)
  • the problem that the medical device taken out from the inside falls from the instrument table, and (3) the problem of volume reduction of the packaging material that becomes waste cannot be solved at all.
  • Patent Document 7 Although the problem of volume reduction of (3) is solved to some extent by using a tray provided with a folding line, the effect is not sufficient, in addition, other problems, in particular, the problem of damage caused by the movement and collision of medical devices during transportation in (1), cannot be solved at all.
  • Patent Documents 8 to 18 also describe a package for preventing breakage during transportation. However, since these are packages that are effectively produced only for specific medical devices, they are described above. As described above, there are so-called customized combination medical devices that correspond to the disease or disease type, operative field and degree, surgical procedure according to it, and the procedures and procedures of hospitals and surgeons. It is not possible to respond. Further, there is no configuration capable of solving the problems (1) to (3) described above.
  • JP 2002-104539 A Japanese Patent No. 3238814 Japanese Patent No. 4933557 JP-A 63-294371 JP-A-8-10243 JP 2008-206568 A Special table 2012-506277 gazette Registered Utility Model Publication No. 3140500 Registered Utility Model Publication No. 3153391 Registered Utility Model Publication No. 3155666 Registered Utility Model Publication No. 3160045 JP 2006-271881 A JP 11-130132 A Japanese Patent No. 2881662 Japanese Patent No. 3944538 Japanese Patent No. 4310088 Japanese Patent No. 4897209 Special table 2008-538526 gazette
  • the present invention provides a medical packaging container for storing various medical device kits used for, for example, surgery, surgical procedures, etc., and the medical devices housed inside during transportation easily move and collide with each other.
  • the medical device can be stored according to the order used in the operation, and the operability when opening in the operating room is good, and the medical device falls from the instrument table when opened. It is another object of the present invention to provide a medical packaging container that can be easily reduced in volume when discarded.
  • the present invention for solving the above problems is a medical packaging container for storing various medical devices, (1) A container body portion having a bottom with an open top, which has a plurality of storage portions and is at least self-supporting while being easily foldable; (2) It is arranged on the upper opening surface of the container main body, and is formed by a film material that is attached to a predetermined portion of the container main body and covers the upper opening of the container main body, According to the shape of the medical device stored in the container main body, the film material is at least partially extended toward the container main body to hold the medical device stored in the container main body in a buffered manner. It is a feature.
  • the film material is stretched so as to have a thickness of 8 to 80% at the maximum stretched portion with respect to the thickness before stretching.
  • the bending resistance of the container main body measured by a cantilever type tester is 1 cm to 30 cm according to JIS L 1096: 2009.
  • the inside of the medical packaging container is 101. , 325 Pa to 800,000 Pa is preferably maintained.
  • the container main body is made of at least one material selected from the group consisting of polyolefin, polyester, and polyamide
  • the film material is made of polyolefin, polyester, Those composed of at least one material selected from the group consisting of polyamides are included.
  • the medical device accommodated in the medical packaging container constitutes a surgical kit comprising a combination of various medical devices required for one operation. Certain embodiments are included.
  • the medical packaging container according to the present invention includes a mode in which the film material covering the upper opening surface of the container main body is attached so as to be opened for each storage part of the container main body.
  • the medical packaging container becomes an inner packaging material in a state where a medical device is housed therein, and further, the inner packaging material is housed inside the outer packaging material, and is sterilized by the outer packaging material. Includes what is packaged.
  • the medical packaging container according to the present invention is preferably sterilized in a state of being sterilized and packaged by the outer packaging material, and the inside of the outer packaging material is preferably maintained in a sterilized state including the inside of the inner packaging material.
  • the medical packaging container according to the present invention includes an embodiment in which the inner packaging material is housed in the outer packaging material after the outer peripheral surface is wrapped with medical sheets.
  • the outer packaging material is (1) a bottomed outer packaging container main body having an opening at the top, which is at least self-supporting and easy to collapse, and (2) What is comprised from the outer packaging film material which is arrange
  • the outer packaging material includes: (1) a bottomed outer packaging container main body having at least self-supporting properties and an upper opening; and (2) disposed on the upper opening surface. And an outer packaging film material that is deposited so as to maintain sterility inside the outer packaging container main body.
  • the medical packaging container of the present invention includes a bottomed container main body having an opening at the top and having a plurality of storage sections. It can be partitioned and stored according to the order of use.
  • the container main body portion is at least self-supporting and easily foldable, it can be held in a state in which a medical container is stored as a container body even after opening, but is easy to dispose of. Volume reduction can be achieved by folding and crushing.
  • the film material which covers this is distribute
  • the medical device accommodated in the inside is gently restrained and held in a shock-absorbing manner.
  • the medical device housed in the medical packaging container of the present invention is coupled with being relatively flexible such that the container body is self-supporting while being easily foldable, Medical equipment during transport because it does not move greatly inside the packaging container due to shaking, vibration, etc. during transport, and is held in a shock-absorbed state with a predetermined distance and distance from each other.
  • Medical equipment during transport because it does not move greatly inside the packaging container due to shaking, vibration, etc. during transport, and is held in a shock-absorbed state with a predetermined distance and distance from each other.
  • they do not break due to contact or collision.
  • sterilization by radiation for example, electron beam sterilization
  • FIG. 1 is a drawing schematically showing the structure of an embodiment of a medical packaging container according to the present invention.
  • FIG. 2 is a drawing schematically showing a configuration in a state where a medical device is housed inside the medical packaging container of the embodiment shown in FIG. 1.
  • FIG. 3 is a drawing schematically showing a deposition structure of a container main body portion and a film material covering the upper opening surface in another embodiment of the medical packaging container according to the present invention.
  • FIG. 4 is a drawing schematically showing a configuration of a buckling-resistant reinforcing groove provided on a side surface of a container main body in another embodiment of the medical packaging container according to the present invention.
  • FIG. 5 is a drawing schematically showing the structure of another embodiment of the medical packaging container according to the present invention.
  • FIG. 6 is a drawing schematically showing the structure of still another embodiment of the medical packaging container according to the present invention.
  • FIG. 1 is a drawing schematically showing the structure of an embodiment of a medical packaging container according to the present invention.
  • the thickness of each member is drawn exaggerated because it is difficult to draw, and is not actual. This also applies to FIG. 2, FIG. 5, and FIG.
  • the medical packaging container 1 of the present invention basically includes a bottomed container main body 10 having an upper opening, and a film material 50 covering the upper opening surface 13 of the container main body 10. Consists of
  • a partition wall 11 is erected from the bottom 12 toward the upper opening surface 13, whereby the interior of the container main body 10 is partitioned into a plurality of storage parts 14 a, 14b, 14c ... are formed.
  • the number, arrangement, size, and the like of each storage unit in the container main body unit 10 is arbitrary, depending on the type, size, quantity, etc. of the medical device to be stored inside Can be changed as appropriate.
  • the container body 10 is at least self-supporting while being easily collapsible.
  • having “self-supporting” means that when the container body 10 is placed on a flat place with the bottom 12 facing down, the outer peripheral side surface 15 can maintain a predetermined height against gravity.
  • the height of the side surface is 100H, the height does not become 50H or less, more preferably 70H or less for at least 24 hours without applying external force. More preferably, it means that it can be maintained without being 80H or less, and most preferably 90H or less.
  • the “self-supporting” has an effect that the medical packaging container 1 gently restrains various medical devices accommodated in the case of sterilization, transportation, etc., and holds it in a shock-absorbing manner.
  • the height of the side surface as 100H may be 100% of the state where the effect is exhibited,
  • the height of the side surface in design, the height immediately after covering the film material 50 after being made into a kit, the height immediately after opening the film material 50 in the operating room, or the like can be given.
  • “easy collapsibility” means that the container body 10 can be deformed by being easily crushed, folded, twisted, or the like by a general person's arm force and can be reduced in volume. As long as such treatment is possible, it is not particularly limited.
  • the index is measured by a cantilever type tester (JIS L 1096: 2009), and the rigidity of the container main body is as follows. For example, it is 30 cm or less, more preferably 25 cm or less, and particularly preferably 23 cm or less.
  • the lower limit of the bending resistance is considered to be about 1 cm, more preferably about 3 cm, and particularly preferably about 5 cm in view of the above-described independence. Since it varies depending on the size of the portion 10, its structure, in particular, the length, number, and arrangement of the partition walls 11 that contribute to the structural strength, it is not particularly limited.
  • the rigidity of the container body is preferably about 1 cm to 30 cm, more preferably 3 cm to 25 cm. It is preferable to be within a range of about.
  • the bend softness test must be performed on both sides of multiple test pieces. The above range is based on the average value.
  • the material constituting the container body 10 As long as it satisfies the condition of “self-supporting” and “easy collapsibility” and can withstand sterilization as described later, the material constituting the container body 10, the thickness, etc. There is no limitation, and various materials can be used.
  • the material constituting the container body 10 include, for example, polyolefins such as polyethylene, polypropylene and ethylene-propylene copolymer, saturated polyesters such as polyethylene terephthalate, chlorinated resins such as polyvinyl chloride and polyvinylidene chloride. Examples thereof include polyamide resins such as nylon and cellulose derivative resins.
  • polyolefins such as polyethylene, polypropylene and ethylene-propylene copolymer
  • saturated polyesters such as polyethylene terephthalate
  • chlorinated resins such as polyvinyl chloride and polyvinylidene chloride.
  • examples thereof include polyamide resins such as nylon and cellulose derivative resins.
  • a laminated structure in which a combination of these materials, or a plurality of the same or different types of these materials are laminated and an aluminum foil or paper It is also possible to use such a composite or a metal vapor deposition film layer partially disposed.
  • a medical device is housed in the container body 10 and a film material 50 is attached to the upper opening to form a package, which will be described later as an inner packaging material, and this inner packaging material is used for sterilization.
  • the inside of the outer packaging material is kept in a sterile state after sterilizing the kit product with the outer packaging material using a sterile packaging material that has a barrier property for sterility maintenance with easy vapor and gas permeability
  • at least the container body 10 on the side of the inner packaging material is not particularly required to have such characteristics, and there are wide choices of materials and specifications that can be used more widely. Become.
  • the film material 50 is made of a sterilization packaging material that has a barrier property for sterility retention as well as easy permeability of vapor and gas for sterilization.
  • a perforation 51 can be provided at an application site of the film material 50 as described later.
  • the outer packaging material must be a sterilization packaging material because it cannot touch sterilization by inserting perforations, but the film material 50 needs to be a permeable material that is easy to sterilize steam or gas. Will disappear and the choice of materials will expand.
  • the film material 50 on the container body 10 may be deposited on a dot pattern such as a dot pattern or a dotted pattern, or a stripe pattern. In some cases, it has the merit of being easy to open.
  • a packaging material having only a barrier property for maintaining sterility. Whether the outer packaging material or both are used as a sterilized packaging material or a packaging material having only a barrier property may be selected by a business operator who manufactures (sterilizes) the kit product.
  • the sterilization packaging material is described as including a packaging material having only barrier properties.
  • packaging with a sterilization packaging material is expressed as sterilization packaging.
  • the molding method of the container body 10 is not particularly limited.
  • various methods such as vacuum molding, pressure molding, hollow molding, and injection molding can be used.
  • the partition wall 11 of the container main body 10 a surface continuous with the bottom surface of the container main body 10 by vacuum forming, pressure forming, hollow forming, or the like (that is, the bottom surface is predetermined) according to the forming method.
  • the partition wall 11 is continuous with the bottom surface of the container main body 10 because of its ease of molding.
  • the surface to be formed is desirably formed by a method such as vacuum forming or pressure forming.
  • the material constituting the container body 10 is a polyolefin-based material, particularly polyethylene.
  • Polypropylene; polyester; or polyamide resin such as nylon is desirable.
  • species of these materials can also be used.
  • the thickness of the material constituting the container body 10 is not particularly limited as long as the requirements of “self-supporting” and “easy folding” are satisfied, as described above.
  • the type of material used, the size of the container body 10, its structure, in particular, the length, number, arrangement, etc. of the partition wall 11 that contributes to the structural strength, and the reinforcing structure as described above It is difficult to define in general because it varies depending on the presence or absence or the weight of the medical container housed inside.
  • the thickness is from another viewpoint such as strength for supporting the contents and resistance to some sudden impact from the outside.
  • the medical device housed therein is securely held inside the container by covering the upper opening surface 13 of the container main body 10.
  • the material, thickness, etc. are not particularly limited, and various materials can be used as long as the material has a strength that can be used and can withstand sterilization as described below.
  • the film material 50 can be adhered (sealed) to the container body 10 through, for example, an adhesive or by being partially fused to the container body 10 by heat sealing. In any case, it is desirable that there is relatively good adhesiveness between the material constituting the film material 50 and the material constituting the container body 10, and although not particularly limited, from this viewpoint
  • the material constituting the film material 50 and the material constituting the container main body 10 are preferably of the same type or similar types, for example.
  • the film material 50 is provided with predetermined various medical devices 70 a, 70 b, 70 c. . . And is attached to a predetermined part of the container body 10 and covers the upper opening surface 13 of the container body 10, and various medical devices 70 a, 70 b, 70 c housed therein. . . .
  • the film material 50 is at least partially elongated toward the container main body side according to the shape of the various medical devices 70a, 70b, 70c. . . It is necessary to arrange the surface of the film material 50 at least locally or close to the surface. For this reason, the film material 50 is required to have sufficient stretchability to withstand such plastic deformation.
  • a method for stretching the film material 50 a method of physically and mechanically pressing, a method of thermally deforming by applying hot air or the like, a method of both heating and physical / mechanical pressing, and further the film material 50 And a method of deforming the film material by temporarily reducing the vacuum pressure or vacuum of the container main body 10 sealed by the above.
  • the various medical devices 70a, 70b, 70c. . . Effects on the environment, ease of construction, and various medical devices 70a, 70b, 70c. . .
  • the film material 50 is not particularly limited when it is thermally deformed, that is, hot stretched, as long as the cutting stretch ratio at least at the optimum heat stretching temperature is somewhat high. It is desirable that the draw ratio is 1.5 times or more, more preferably 3 times or more, and even more preferably 5 times or more.
  • the cutting draw ratio means a value measured based on JIS K 7127: “Plastic—Test Method for Tensile Properties”. The outline is that a strip-shaped test piece having a width of 15.0 mm is prepared, an initial distance between chucks is set to 50.0 mm, a distance between marked lines is set to 50.0 mm, and a tensile tester according to the ISO 5893 standard is used. Test temperature: 103.0 ° C., load range: 100.0 N, test speed: 200.0 mm / min.
  • the method of thermally deforming and extending the film material 50 is not particularly limited, but various medical devices 70a, 70b, 70c. . . Depending on the shape of the film, it is possible to change the degree of elongation for each part and process it from the outside of the container in a non-contact manner. For example, hot air or steam (steam) is spotted on the film material.
  • a method of processing while appropriately changing the processing time for each part can be preferably exemplified.
  • the film material covering the upper opening surface 13 of the container main body 10 is made into various medical devices 70a, 70b, 70c. . . Depending on the shape of the medical device 70a, 70b, 70c. Stored in the container body by at least partially extending toward the container body. . . Are gently restrained by the stretched film material 50, and the various medical devices 70a, 70b, 70c. . . Can be held buffered.
  • the extent of the extension of the film material 50 depends on the various medical devices 70a, 70b, 70c. . . Depending on the type, shape and amount of storage, etc., the degree of effective buffering varies, so it is difficult to prescribe at a glance, but for example, for the thickness of the film material 50 before stretching, It is stretched to a thickness of 8 to 80% at its maximum stretched site, more preferably to a thickness of 20 to 60%, and even more preferably to a thickness of 30 to 50%. In general, it is effective. In this way, the film material 50 is made up of the medical devices 70a, 70b, 70c. . . The film material 50 is hardly stretched in the vicinity of the edge of the packaging container, for example, and is particularly limited. However, it is often about 100% to 80% with respect to the thickness of the film material 50 before stretching.
  • the various medical devices 70a, 70b, 70c. . . Is controlled to some extent by the film material 50 stretched on the inside of the container, but is loosely restrained by a highly flexible material such as the stretched film material, and is completely medical.
  • Devices 70a, 70b, 70c. . . Of the medical devices 70a, 70b, 70c. . . Can move within a certain range within the packaging container.
  • the partition wall 11 and / or the bottom 12 is further stretched toward the inside of the container. It is possible to strengthen it.
  • the medical device is stored in the packaging container together with the presence of the partition wall 11 described above.
  • the void ratio in the medical container 1 and the flexibility of the container main body 10, in other words, “easy collapsibility” also contribute to the effect.
  • the inside of the medical packaging container 1 is It is desirable to maintain the pressure at about atmospheric pressure or slightly reduced pressure, for example, about 101,325 Pa to 800,000 Pa, more preferably about 101,325 to 100,000 Pa.
  • the inside is, for example, vacuum packaging or the like
  • the wall surface of the packaging container and the wall surface of the medical device housed inside are not in close contact with each other, and a certain amount of space is created.
  • the film material 50 is disposed on the upper opening surface of the container main body 10, and a flange portion 17 provided at a predetermined portion of the container main body, for example, the peripheral edge of the upper opening 13 of the container main body 10.
  • the film member 50 is attached to the upper end surface portion of the partition wall 11 and covers the upper opening surface of the container main body portion.
  • Each of the storage portions 14a, 14b, 14c, 14d,... Is configured as a plurality of film materials corresponding to the storage portions 14a, 14b, 14c, 14d, or schematically shown in FIG. As shown in FIG. 4, along the shape of each of the storage portions 14a, 14b, 14c, 14d ... Can be provided .
  • body fluids such as sweat and blood that are released or scattered by the patient and medical personnel are configured by opening the film material for each of the storage portions 14a, 14b, 14c, 14d.
  • the aseptic condition can be maintained in a sanitary condition with the upper opening of the medical packaging container covered with a film material until just before each medical device is used. It is possible to avoid contamination as much as possible.
  • the film material 50 is provided with an easily separated cutting structure such as the perforation 51, the sterility of the inside is not guaranteed. In such a case, as described later, these medical treatments are not guaranteed. If the medical container containing the device is used as an inner packaging material, and this inner packaging material is further stored inside the outer packaging material and sterilization packaging is ensured by the outer packaging material, it is stored inside during the transportation and storage period until use. The problem of sterilization of the used medical device does not occur.
  • the attachment of the container body 10 that is the inner packaging material and the film material 50 does not particularly require sterilization packaging properties.
  • a form such as a dot pattern or a stripe pattern without closely adhering the entire surface of the part to be adhered around the outer edge of both members. It is also possible to adopt a mode in which the contact is made in contact with the surface.
  • the medical devices 70a, 70b, 70c Stored in the medical packaging container 1 according to the present invention. . .
  • various medical devices required for surgery, surgical procedures, and the like can be appropriately combined and stored according to the request of the hospital or the like.
  • general surgical instruments such as scalpels, clamps, suture needles, sutures, cannulas, catheters, etc., which are required according to individual surgical contents, such as artificial organs, indwelling instruments
  • Examples include medical devices for endovascular treatment, liquids such as disinfectant solution and Ringer's solution, surgical clothes worn by medical workers or patients such as gowns, gloves, masks, drapes, etc. It is not limited to what was illustrated.
  • the medical devices 70a, 70b, 70c. . . Can be housed inside the medical packaging container 1 according to the present invention in a state of being individually sterilized and packaged, but it is time-consuming to perform the operation of opening them sequentially in the operating room. It cannot be said that it is not preferable at the time of a surgery with big restrictions.
  • the medical packaging container 1 according to the present invention since it is possible to guarantee the sterilization state in the entire interior, the medical devices 70a, 70b, 70c. . . It is more desirable that the product is stored in the medical packaging container 1 without such individual sterilization packaging.
  • the medical packaging container 1 includes medical devices 70a, 70b, 70c. . . Are stored in the storage unit 14 according to different characteristics, so that the characteristics, for example, medical device classification (highly managed medical device, managed medical device or general medical device) defined in the Pharmaceutical Affairs Law, or clean It is also possible to correspond to the size, size, etc.
  • FIG. 5 is a drawing schematically showing a structure in another embodiment of the medical packaging container according to the present invention.
  • the container body 10 has a plurality of compartments 14 and is at least self-supporting while being easily foldable. Inside the medical devices 70a, 70b, 70c. . . , Covering the upper opening surface 13 of the container body 10, and applying the film material 50, and medical devices 70 a, 70 b, 70 c. . . In accordance with the shape of the medical packaging container 1 in which the film material 50 is at least partially extended toward the container main body 10 side as an inner packaging material, the inner packaging material is further housed inside the outer packaging material 100, The outer packaging material is sterilized and packaged.
  • the outer packaging material 100 includes a bottomed outer packaging container main body portion 110 having an upper opening, and an outer packaging film material 150 that covers the upper opening surface 113 of the outer packaging container main body portion 110. ing.
  • the outer container body 110 in this embodiment has basically the same configuration as the container body 10 shown in FIGS. 1 and 2 except that the interior is not divided into a plurality of parts. That is, the outer packaging container main body 110 is at least self-supporting while being easily foldable as described above, and the materials, manufacturing method, and the like used for this can be the same.
  • the envelope film material 150 in this embodiment can be basically the same as the film material 50 shown in FIGS. 1 and 2, but the envelope film material 150 is similar to that shown in FIGS.
  • various medical devices 70a, 70b, 70c. . . According to the shape of the container body, it is not at least partially extended toward the container body part side, but is simply attached so as to cover the upper opening surface 113 of the outer container body part 110.
  • the outer packaging material when the outer packaging material is further included, the outer packaging material is sterilized with the inner packaging material stored therein.
  • the film material 150 that covers the self-contained outer packaging container main body 110 and its upper end opening 113 while being easily foldable.
  • an aspect using a more rigid material is also desired.
  • the outer packaging material is removed in advance immediately before the product is brought into the operating room to reduce the volume of medical waste generated in the operating room. Is also possible.
  • the structure when the structure further includes the outer packaging material as described above, the handling property during transportation and storage and the prevention of breakage of the packaging container itself are enhanced, and the various medical devices 70a, 70b, 70c. . . As a result, sterility is also ensured.
  • the perforated portion is provided in the adhering portion of the packaging container main body portion 10 as the inner packaging material and the film material 50, or the adhering structure has a releasability such as a dot pattern. Since it is difficult to maintain a completely sterilized state on the inner packaging material side, it is effective in terms of sterilization to further provide the outer packaging material.
  • the medical device is arranged not only inside the packaging container 1 serving as the inner packaging material but also between the packaging container 1 serving as the inner packaging material and the outer packaging material 100. It is also possible to adopt.
  • a medical device that has a relatively large area, such as a drape or a gown, but has a low risk of breakage and can be folded flat in shape includes a packaging container 1 serving as an inner packaging material. Arranged between the outer packaging material 100 and other instruments by colliding with smaller instruments, those that are not deformed and bulky or have special shapes, those that are easily damaged, or conversely, collide with other instruments.
  • a highly rigid material that is highly likely to be damaged may be disposed inside the packaging container 1 that is an inner packaging material.
  • the medical device used for the existing surgery can adopt a surgical preparation method in which aseptic conditions can be maintained until immediately before the surgery starts.
  • the outer packaging material is present only at the time of transportation and storage, and is opened immediately before its use, for example, immediately before being carried into the operating room.
  • the operating room is housed in the inner packaging material and the interior thereof. An embodiment in which only a medical device is brought in can also be adopted.
  • FIG. 6 is a drawing schematically showing a structure in still another embodiment of the medical packaging container according to the present invention.
  • the configuration further includes the outer packaging material 100, not only the inside of the packaging container 1 serving as the inner packaging material, but also between the packaging container 1 serving as the inner packaging material and the outer packaging material 100.
  • a medical packaging container 1 serving as an inner packaging material is housed in the outer packaging material 100 after its outer peripheral surface is wrapped with a medical sheet 200.
  • the medical sheet refers to a sheet-like material including an instrument table cover, a sterilization wrap material, and a surgical drape.
  • the various medical devices 70a, 70b, 70c. . . Since the medical packaging container 1 as an inner packaging material that is housed inside can be placed in a form placed on the top thereof, preparation for surgery and the like is more preferable.
  • the medical packaging container 1 as an inner packaging material is stored in the top and bottom, that is, on the bottom surface side of the outer packaging container main body 110, the upper portion (film material) of the medical packaging container 1 as the inner packaging material. 50 side).
  • the outer packaging film material 150 covering the upper part of the outer packaging material 100 is peeled off and opened, the outer packaging container body 110 is inverted, and the contents are placed on the instrument table in the operating room.
  • the outer packaging material 100 is inverted in advance, and then the outer packaging container body 110 is peeled off from the outer packaging film material 150 covering the upper part and opened, and the contents are taken out immediately on the instrument table.
  • Various medical devices 70a, 70b, 70c. . . Can be arranged as a form in which the medical packaging container 1 as an inner packaging material is placed.
  • the outer packaging material 100 is inverted in advance and the outer packaging container body 110 is removed, the outer packaging film material 150 remains on the instrument table, the instrument table cover is developed thereon, and the medical packaging is further formed thereon.
  • the surface of the outer cover film material 150 that is in contact with the instrument table cover is a sterilized surface, even if the instrument table cover is damaged during operation, a hole is opened in the sheet. If not, cleanliness is maintained, and the instrument table is less likely to get dirty even if chemicals are spilled.
  • the medical devices 70a, 70b, 70c. . . In the medical packaging container according to the present invention, the medical devices 70a, 70b, 70c. . . In the embodiment further comprising the outer packaging material 100 as shown in FIGS. 5 and 6, after the packaging is completed by attaching the film material 50 covering the upper opening surface 13 of the container main body portion 10. Further, the packaging container 1 to be the inner packaging material is accommodated in the outer packaging material 100, and after the packaging is completed by attaching, the sterilization is performed and the medical devices 70a, 70b, 70c accommodated in the inner packaging material 100 are contained. . . .
  • the sterilization method used in this case is not particularly limited, and known methods such as ethylene oxide gas (EOG) sterilization method, electron beam or gamma irradiation sterilization method, etc. Any sterilization method can be utilized.
  • EOG ethylene oxide gas
  • Example 1 A laminated sheet (thickness 300 ⁇ m) made of polyethylene and polyamide was vacuum-formed to produce a tray-shaped packaging container main body 10 having a plurality of compartments as shown in FIG.
  • the outer dimensions of the obtained packaging container main body 1 were 500 mm long, 420 mm wide and 150 mm deep, and four compartments having different sizes and lengths were formed inside. Further, although the thickness varies depending on the portion, for example, the thickness of the bottom four corners of the compartment is about 25 to 57 ⁇ m.
  • the medical packaging container 1 When the height of the packaging container body 10 is 100H, the medical packaging container 1 is empty, and the partition wall 11 can be arranged so that the bottom 12 and the upper opening surface 13 are parallel to each other. After extending by hand as much as possible, the height did not become 90H or less for at least 24 hours without applying external force, and it was self-supporting.
  • a part of the wall surface of the obtained packaging container main body 10 was cut out to prepare a strip-like sample having a width of 25 mm, and the bending resistance was measured with a cantilever tester (manufactured by Toyo Seiki) in accordance with JIS L 1096: 2009.
  • the storage part 14a stores a cotton ball, a disinfection container, gauze, and the storage part 14b stores a syringe, an injection needle, a knife replacement blade, and an electric knife replacement blade.
  • Part 14C contains sutures, suture needles, vascular tape, needle holders and staplers, and storage part 14d contains containers, suction tubes, suction tubules, suction valves, suture needle counters, and drapes. From there, a polyethylene film (thickness 130 ⁇ m) was placed, and this film 50 was applied to the upper peripheral edge flange portion of the packaging container main body portion 10 by heat sealing so as to be aseptically held. (At this time, the area of the film 50 is 100% of the area of the upper opening surface of the container body 10).
  • the stretched film 50 had a thickness of 10 to 122 ⁇ m depending on each part, and was 8% to 93.8% of the unstretched film.
  • the medical packaging container containing the medical device manufactured in this way was actually transported from Ibaraki Prefecture to Osaka Prefecture.
  • the film 50 was broken, the medical device as the contents was taken out, and the sterility was investigated by a sterility test, but the bacterial cell group was not observed and the sterility was maintained at a high level. I also understood that.
  • Reference example 1 For reference, a test piece was cut out in an unprocessed state from the laminated sheet made of polyethylene and polyamide used to produce the packaging container body 10 in Example 1, and the stiffness was measured by a cantilever testing machine similar to Example 1. Subjected to softness test. The obtained results are shown in Table 1.
  • Reference example 2 For reference, Tyvek (manufactured by DuPont), which has been conventionally used as a medical packaging material, was subjected to a stiffness test using a cantilever tester in the same manner as in Reference Example 1. The obtained results are shown in Table 1.
  • Comparative Example 3 For reference, a polypropylene tray (Reference Example 3), a commercially available polypropylene hard blister (Reference Example 4), and a commercially available plastic bag (produced by Nippon Shokubai, Unipack) (Reference Example 5) are similarly cantilevers. It was subjected to a bending resistance test using a testing machine. The obtained results are shown in Table 1.
  • a kit consisting of various medical devices required for surgery, etc. is packaged and stored in a sterile state, and the medical device stored in the inside is not damaged and is reliably maintained in a sterile state to the medical site. Since the various medical devices that have been transported, opened in the operating room, and housed inside can be used efficiently, it is possible to contribute to safety and efficiency in the medical field, particularly in surgical operations. Is.

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  • Engineering & Computer Science (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
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  • General Health & Medical Sciences (AREA)
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Abstract

La présente invention concerne un récipient d'emballage médical destiné au conditionnement de divers types de dispositifs médicaux, ledit récipient d'emballage médical comprenant : (1) une partie formant le corps du récipient qui est fermée au niveau d'une extrémité et ouverte à son sommet, qui comporte des parties de stockage séparées, qui est autoportante et peut être aisément repliée et contractée ; et (2) un matériau de type film qui est disposé sur la face supérieure ouverte de la partie formant le corps du récipient, qui recouvre une partie prédéterminée de ladite partie formant le corps du récipient et recouvre la face supérieure ouverte de la partie formant le corps du récipient. Ledit récipient d'emballage médical est caractérisé en ce que le matériau de type film est au moins partiellement étiré en direction du côté de la partie formant le corps du récipient en fonction de la forme d'un dispositif médical conditionné dans la partie formant le corps du récipient et en ce que ledit matériau de type film maintient, de façon à amortir les chocs, le dispositif médical conditionné dans ladite partie formant le corps du récipient.
PCT/JP2012/079830 2012-11-16 2012-11-16 Récipient d'emballage médical Ceased WO2014076819A1 (fr)

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WO2017132024A1 (fr) * 2016-01-29 2017-08-03 Miki Roberto Augusto Kit d'implantation chirurgical de guide de croissance de limbe
WO2019078361A1 (fr) * 2017-10-20 2019-04-25 テルモ株式会社 Récipient de stockage, élément d'emballage et ensemble d'instruments médicaux
WO2020250988A1 (fr) * 2019-06-11 2020-12-17 株式会社ジェイ・エム・エス Récipient médical
JP2020199108A (ja) * 2019-06-11 2020-12-17 株式会社ジェイ・エム・エス 医療用容器
EP4000585A4 (fr) * 2019-07-18 2023-02-08 Daikyo Seiko, LTD. Dispositif médical emballé et procédé de fabrication de dispositif médical emballé
JP2023104514A (ja) * 2022-01-18 2023-07-28 テルモ株式会社 医療機器包装体
WO2024210257A1 (fr) * 2023-04-05 2024-10-10 원광대학교산학협력단 Kit d'article médical emballé stérile
KR102920307B1 (ko) * 2023-04-05 2026-02-02 원광대학교산학협력단 멸균포장된 의료용품키트

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JP3140500U (ja) * 2008-01-16 2008-03-27 株式会社テクノメデイカ 採血キット
JP2010036961A (ja) * 2008-08-06 2010-02-18 Ii P I:Kk 小形製品包装体および小形製品の包装方法

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JP3140500U (ja) * 2008-01-16 2008-03-27 株式会社テクノメデイカ 採血キット
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Cited By (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10806492B2 (en) 2016-01-29 2020-10-20 Roberto Augusto Miki Nail plate growth guide surgical implantation kit
WO2017132024A1 (fr) * 2016-01-29 2017-08-03 Miki Roberto Augusto Kit d'implantation chirurgical de guide de croissance de limbe
US10327814B2 (en) 2016-01-29 2019-06-25 Roberto Augusto Miki Nail plate growth guide surgical implantation kit
JP7123957B2 (ja) 2017-10-20 2022-08-23 テルモ株式会社 収納容器、包装部材、及び医療器具セット
CN111093751B (zh) * 2017-10-20 2022-04-29 泰尔茂株式会社 收纳容器、包装部件及医疗器具组件
JPWO2019078361A1 (ja) * 2017-10-20 2020-11-05 テルモ株式会社 収納容器、包装部材、及び医療器具セット
US11751969B2 (en) 2017-10-20 2023-09-12 Terumo Kabushiki Kaisha Storage container, packaging member, and medical instrument set
CN111093751A (zh) * 2017-10-20 2020-05-01 泰尔茂株式会社 收纳容器、包装部件及医疗器具组件
WO2019078361A1 (fr) * 2017-10-20 2019-04-25 テルモ株式会社 Récipient de stockage, élément d'emballage et ensemble d'instruments médicaux
EP3984901A4 (fr) * 2019-06-11 2023-05-03 JMS Co., Ltd. Récipient médical
CN113924256A (zh) * 2019-06-11 2022-01-11 株式会社Jms 医疗用容器
JP2020199108A (ja) * 2019-06-11 2020-12-17 株式会社ジェイ・エム・エス 医療用容器
JP7279531B2 (ja) 2019-06-11 2023-05-23 株式会社ジェイ・エム・エス 医療用容器
WO2020250988A1 (fr) * 2019-06-11 2020-12-17 株式会社ジェイ・エム・エス Récipient médical
CN113924256B (zh) * 2019-06-11 2024-03-12 株式会社Jms 医疗用容器
EP3984901B1 (fr) * 2019-06-11 2024-06-26 JMS Co., Ltd. Récipient médical
US12377418B2 (en) 2019-06-11 2025-08-05 Jms Co., Ltd. Medical container
EP4000585A4 (fr) * 2019-07-18 2023-02-08 Daikyo Seiko, LTD. Dispositif médical emballé et procédé de fabrication de dispositif médical emballé
JP2023104514A (ja) * 2022-01-18 2023-07-28 テルモ株式会社 医療機器包装体
WO2024210257A1 (fr) * 2023-04-05 2024-10-10 원광대학교산학협력단 Kit d'article médical emballé stérile
KR102920307B1 (ko) * 2023-04-05 2026-02-02 원광대학교산학협력단 멸균포장된 의료용품키트

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